memantine HCl 5 MG Oral Tablet
- RxCUI
- 996571
- RxNorm name
- memantine HCl 5 MG Oral Tablet
- Display name
- memantine HCl 5 MG Oral Tablet
- Full name
- memantine HCl 5 MG Oral Tablet
- Term type
- PSN
- Status
- DailyMed mapping
- Updated
- 2026-06-04 23:39:10
UNII Substances#
No records found.
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Memantine | MEMANTINE | NorthStar RxLLC | 7a40ed9d-8853-b616-ff47-0c7b0fd28959 | 2023-12-26 | Warnings, Adverse reactions | 996571 |
| Memantine Hydrochloride | MEMANTINE HYDROCHLORIDE | A-S Medication Solutions | 2fdf0b2b-0337-472d-83ec-075c17c9b0d0 | 2023-11-22 | Warnings, Adverse reactions | 996571 |
| Memantine Hydrochloride | MEMANTINE HYDROCHLORIDE | Sun Pharmaceutical Industries, Inc. | d1963395-3cf7-4433-bf2c-06295bb1c5b0 | 2023-10-05 | Warnings, Adverse reactions | 996571 |
| Memantine Hydrochloride | MEMANTINE HYDROCHLORIDE | Bryant Ranch Prepack | 9cfddd01-6e1d-4ee0-9310-3fb371724e3d | 2023-10-04 | Warnings, Adverse reactions | 996571 |
| Memantine hydrochloride | MEMANTINE | Amneal Pharmaceuticals of New York LLC | 054069b5-7aac-4106-821f-ebf7fd531b4f | 2023-08-17 | Warnings, Adverse reactions | 996571 |
| Memantine Hydrochloride | MEMANTINE HYDROCHLORIDE | Bryant Ranch Prepack | 8bd5b908-f46a-4ced-9408-45984d716149 | 2023-03-24 | Warnings, Adverse reactions | 996571 |
| Memantine Hydrochloride | MEMANTINE HYDROCHLORIDE | Bryant Ranch Prepack | 2bd37a6f-bdeb-42c2-9f03-fbf06b45cfe0 | 2023-03-03 | Warnings, Adverse reactions | 996571 |
| Memantine Hydrochloride | MEMANTINE HYDROCHLORIDE | Bryant Ranch Prepack | fac8c59b-5bf5-478e-8223-a5ecaa400625 | 2023-03-03 | Warnings, Adverse reactions | 996571 |
| memantine | MEMANTINE | Chartwell RX, LLC | 6906b0b4-1944-40f0-844a-e0db72ba4675 | 2023-02-02 | Warnings, Adverse reactions | 996571 |
| Memantine Hydrochloride | MEMANTINE HYDROCHLORIDE | Alembic Pharmaceuticals Limited | b86c0f6e-480b-40e7-aa4d-21bd0659101d | 2023-01-30 | Warnings, Adverse reactions | 996571 |
| Memantine Hydrochloride | MEMANTINE HYDROCHLORIDE | Macleods Pharmaceuticals Limited | 989fa756-7d70-4ea7-bb5e-f4395e48589d | 2022-12-31 | Warnings, Adverse reactions | 996571 |
| Memantine Hydrochloride | MEMANTINE HYDROCHLORIDE | Aurobindo Pharma Limited | ceb733fa-4526-4b76-ab6a-bd4c5638afff | 2022-11-08 | Warnings, Adverse reactions | 996571 |
| memantine hydrochloride | MEMANTINE HYDROCHLORIDE | Camber Pharmaceuticals, Inc. | 910827aa-5320-446c-8f66-3f17c0ee36d9 | 2022-10-11 | Warnings, Adverse reactions | 996571 |
| Memantine Hydrochloride | MEMANTINE HYDROCHLORIDE | Viona Pharmaceuticals Inc | dcbdb62a-a4e2-4058-b73c-46005f2a5d51 | 2022-10-08 | Warnings, Adverse reactions | 996571 |
| Memantine Hydrochloride | MEMANTINE HYDROCHLORIDE | Alembic Pharmaceuticals Inc. | af2b73da-1be4-4b7f-929b-acb3b9a10f78 | 2021-10-11 | Warnings, Adverse reactions | 996571 |
| Memantine Hydrochloride | MEMANTINE HYDROCHLORIDE | Unichem Pharmaceuticals (USA), Inc. | ff74edcb-d7ed-4b70-8f22-4cb5ccc58f90 | 2020-12-07 | Warnings, Adverse reactions | 996571 |
| Memantine Hydrochloride | MEMANTINE HYDROCHLORIDE | Dr. Reddys Laboratories Limited | a71e2482-5266-d03e-8b36-862afe78c9a4 | 2019-02-08 | Warnings, Adverse reactions | 996571 |
| memantine hydrochloride | MEMANTINE HYDROCHLORIDE | Actavis Pharma, Inc. | 72973b46-f307-4a9e-8fb1-ad2cbccfd736 | 2018-11-01 | Warnings, Adverse reactions | 996571 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed RxNorm Mappings#
| Set ID | RxNorm mappings | Terms | SPL version | Label | Effective |
|---|---|---|---|---|---|
| 9cfddd01-6e1d-4ee0-9310-3fb371724e3d | memantine HCl 5 MG Oral Tablet [PSN] · memantine hydrochloride 5 MG Oral Tablet [SCD] | 2 | 103 | These highlights do not include all the information needed to use MEMANTINE HYDROCHLORIDE safely and effectively. See full prescribing information for MEMANTINE HYDROCHLORIDE. MEMANTINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 2003 | 20231004 |
| 2bd37a6f-bdeb-42c2-9f03-fbf06b45cfe0 | memantine HCl 5 MG Oral Tablet [PSN] · memantine hydrochloride 5 MG Oral Tablet [SCD] | 2 | 102 | These highlights do not include all the information needed to use MEMANTINE HYDROCHLORIDE safely and effectively. See full prescribing information for MEMANTINE HYDROCHLORIDE. MEMANTINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 2003 | 20230303 |
| fac8c59b-5bf5-478e-8223-a5ecaa400625 | memantine HCl 5 MG Oral Tablet [PSN] · memantine hydrochloride 5 MG Oral Tablet [SCD] | 2 | 102 | These highlights do not include all the information needed to use MEMANTINE HYDROCHLORIDE safely and effectively. See full prescribing information for MEMANTINE HYDROCHLORIDE. MEMANTINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 2003 | 20230303 |
| 8bd5b908-f46a-4ced-9408-45984d716149 | memantine HCl 5 MG Oral Tablet [PSN] · memantine hydrochloride 5 MG Oral Tablet [SCD] | 2 | 101 | These highlights do not include all the information needed to use MEMANTINE HYDROCHLORIDE safely and effectively. See full prescribing information for MEMANTINE HYDROCHLORIDE. MEMANTINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 2003 | 20230324 |
| 0ad2246a-ffa0-43a0-8094-58279d3e3a74 | memantine HCl 5 MG Oral Tablet [PSN] · memantine hydrochloride 5 MG Oral Tablet [SCD] | 2 | 100 | These highlights do not include all the information needed to use MEMANTINE HYDROCHLORIDE safely and effectively. See full prescribing information for MEMANTINE HYDROCHLORIDE. MEMANTINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 2003 | 20240206 |
| d77172c4-f84a-4310-907f-7222d330a383 | memantine HCl 5 MG Oral Tablet [PSN] · memantine hydrochloride 5 MG Oral Tablet [SCD] | 2 | 100 | These highlights do not include all the information needed to use memantine hydrochloride safely and effectively. See full prescribing information for memantine hydrochloride. MEMANTINE hydrochloride tablets, for oral use Initial U.S. Approval: 2003 | 20211220 |
| 054069b5-7aac-4106-821f-ebf7fd531b4f | memantine HCl 5 MG Oral Tablet [PSN] · memantine hydrochloride 5 MG Oral Tablet [SCD] | 2 | 19 | These highlights do not include all the information needed to use MEMANTINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for MEMANTINE HYDROCHLORIDE TABLETS. MEMANTINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 2003 | 20230817 |
| 1b4a0162-9cb4-4ba6-8c02-95c2955734ae | memantine HCl 5 MG Oral Tablet [PSN] · memantine hydrochloride 5 MG Oral Tablet [SCD] | 2 | 13 | These highlights do not include all the information needed to use MEMANTINE HYDROCHLORIDE TABLETS USP safely and effectively. See full prescribing information for MEMANTINE HYDROCHLORIDE TABLETS USP. MEMANTINE hydrochloride tablets USP, for oral use Initial U.S. Approval: 2003 | 20251229 |
| d1963395-3cf7-4433-bf2c-06295bb1c5b0 | memantine HCl 5 MG Oral Tablet [PSN] · memantine hydrochloride 5 MG Oral Tablet [SCD] | 2 | 13 | These highlights do not include all the information needed to use memantine hydrochloride tablets safely and effectively. See full prescribing information for memantine hydrochloride tablets. MEMANTINE hydrochloride tablets, for oral use Initial U.S. Approval: 2003 | 20231005 |
| af2b73da-1be4-4b7f-929b-acb3b9a10f78 | memantine HCl 5 MG Oral Tablet [PSN] · memantine hydrochloride 5 MG Oral Tablet [SCD] | 2 | 13 | These highlights do not include all the information needed to use MEMANTINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for MEMANTINE HYDROCHLORIDE TABLETS. MEMANTINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 2003 | 20211011 |
| a5dcc0e7-761f-4294-bb48-e5ee4a1e2f67 | memantine HCl 5 MG Oral Tablet [PSN] · memantine hydrochloride 5 MG Oral Tablet [SCD] | 2 | 11 | These highlights do not include all the information needed to use MEMANTINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for MEMANTINE HYDROCHLORIDE TABLETS. MEMANTINE HYDROCHLORIDE tablets , for oral use Initial U.S. Approval: 2003 | 20240812 |
| 6e0ade9e-b721-4701-bcb7-de464e19e707 | memantine HCl 5 MG Oral Tablet [PSN] · memantine hydrochloride 5 MG Oral Tablet [SCD] | 2 | 10 | These highlights do not include all the information needed to use MEMANTINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for MEMANTINE HYDROCHLORIDE TABLETS. MEMANTINE HYDROCHLORIDE Tablets, for oral use Initial U.S. Approval: 2003 | 20251211 |
| 72973b46-f307-4a9e-8fb1-ad2cbccfd736 | memantine HCl 5 MG Oral Tablet [PSN] · memantine hydrochloride 5 MG Oral Tablet [SCD] | 2 | 10 | These highlights do not include all the information needed to use MEMANTINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for MEMANTINE HYDROCHLORIDE TABLETS . MEMANTINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 2003 | 20181101 |
| 65c9e7bc-71f0-4113-8de1-4fcaa591735f | memantine HCl 5 MG Oral Tablet [PSN] · memantine hydrochloride 5 MG Oral Tablet [SCD] | 2 | 9 | These highlights do not include all the information needed to use MEMANTINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for MEMANTINE HYDROCHLORIDE TABLETS. MEMANTINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 2003 | 20260115 |
| f73e0df0-4af4-42f1-bde6-3cccb47ca378 | memantine HCl 5 MG Oral Tablet [PSN] · memantine hydrochloride 5 MG Oral Tablet [SCD] | 2 | 9 | These highlights do not include all the information needed to use MEMANTINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for MEMANTINE HYDROCHLORIDE TABLETS. MEMANTINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 2003 | 20251220 |
| 292671f2-f221-4a3d-a110-a266a9527e04 | memantine HCl 5 MG Oral Tablet [PSN] · memantine hydrochloride 5 MG Oral Tablet [SCD] | 2 | 9 | These highlights do not include all the information needed to use MEMANTINE hydrochloride tablets safely and effectively. See full prescribing information for MEMANTINE hydrochloride tablets. MEMANTINE hydrochloride tablets, for oral use Initial U.S. Approval: 2003 | 20251127 |
| ceb733fa-4526-4b76-ab6a-bd4c5638afff | memantine HCl 5 MG Oral Tablet [PSN] · memantine hydrochloride 5 MG Oral Tablet [SCD] | 2 | 9 | These highlights do not include all the information needed to use MEMANTINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for MEMANTINE HYDROCHLORIDE TABLETS. MEMANTINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 2003 | 20221108 |
| d0a5e0fc-04e3-417d-bef3-9b309ff71597 | memantine HCl 5 MG Oral Tablet [PSN] · memantine hydrochloride 5 MG Oral Tablet [SCD] | 2 | 8 | These highlights do not include all the information needed to use MEMANTINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for MEMANTINE HYDROCHLORIDE TABLETS. MEMANTINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 2003 | 20251204 |
| cbfd9d95-f50b-45ff-9857-9f1712c45e56 | memantine HCl 5 MG Oral Tablet [PSN] · memantine hydrochloride 5 MG Oral Tablet [SCD] | 2 | 7 | These highlights do not include all the information needed to use MEMANTINE HYDROCHLORIDE safely and effectively. See full prescribing information for MEMANTINE HYDROCHLORIDE. MEMANTINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 2003 | 20260408 |
| 304a3059-4f7f-4ec4-839d-86492bb5e07b | memantine HCl 5 MG Oral Tablet [PSN] · memantine hydrochloride 5 MG Oral Tablet [SCD] | 2 | 7 | These highlights do not include all the information needed to use MEMANTINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for MEMANTINE HYDROCHLORIDE TABLETS. MEMANTINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 2003 | 20250422 |
| e5754973-e73b-4a25-abb4-80f91880f018 | memantine HCl 5 MG Oral Tablet [PSN] · memantine hydrochloride 5 MG Oral Tablet [SCD] | 2 | 7 | These highlights do not include all the information needed to use MEMANTINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for MEMANTINE HYDROCHLORIDE TABLETS. MEMANTINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 2003 | 20250128 |
| 514421f3-f525-43e8-aecc-8b2bbffd00dc | memantine HCl 5 MG Oral Tablet [PSN] · memantine hydrochloride 5 MG Oral Tablet [SCD] | 2 | 7 | MEMANTINE HYDROCHLORIDE TABLETS | 20240816 |
| f05e381f-850d-42ea-9dd8-6d1f8dac4f62 | memantine HCl 5 MG Oral Tablet [PSN] · memantine hydrochloride 5 MG Oral Tablet [SCD] | 2 | 6 | These highlights do not include all the information needed to use MEMANTINE HYDROCHLORIDE safely and effectively. See full prescribing information for MEMANTINE HYDROCHLORIDE. MEMANTINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 2003 | 20240530 |
| 2fdf0b2b-0337-472d-83ec-075c17c9b0d0 | memantine HCl 5 MG Oral Tablet [PSN] · memantine hydrochloride 5 MG Oral Tablet [SCD] | 2 | 6 | These highlights do not include all the information needed to use MEMANTINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for MEMANTINE HYDROCHLORIDE TABLETS. MEMANTINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 2003 | 20231122 |
| 989fa756-7d70-4ea7-bb5e-f4395e48589d | memantine HCl 5 MG Oral Tablet [PSN] · memantine hydrochloride 5 MG Oral Tablet [SCD] | 2 | 6 | HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use MEMANTINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for MEMANTINE HYDROCHLORIDE TABLETS MEMANTINE HYDROCHLORIDE TABLETS, for oral use Initial U.S. Approval: 2003 | 20221231 |
| a71e2482-5266-d03e-8b36-862afe78c9a4 | memantine HCl 5 MG Oral Tablet [PSN] · memantine hydrochloride 5 MG Oral Tablet [SCD] | 2 | 6 | These highlights do not include all the information needed to use MEMANTINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for MEMANTINE HYDROCHLORIDE TABLETS. MEMANTINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 2003 | 20190208 |
| ff74edcb-d7ed-4b70-8f22-4cb5ccc58f90 | memantine HCl 5 MG Oral Tablet [PSN] · memantine hydrochloride 5 MG Oral Tablet [SCD] | 2 | 5 | These highlights do not include all the information needed to use MEMANTINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for MEMANTINE HYDROCHLORIDE TABLETS. MEMANTINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 2003 | 20201207 |
| d0839a2d-35f1-1f14-e053-2995a90ad549 | memantine HCl 5 MG Oral Tablet [PSN] · memantine hydrochloride 5 MG Oral Tablet [SCD] | 2 | 4 | Memantine HCL | 20260306 |
| c343b0c5-3bfc-4b94-9483-a56924f6dcdb | memantine HCl 5 MG Oral Tablet [PSN] · memantine hydrochloride 5 MG Oral Tablet [SCD] | 2 | 4 | These highlights do not include all the information needed to use MEMANTINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for MEMANTINE HYDROCHLORIDE TABLETS. MEMANTINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 2003 | 20221201 |
| b86c0f6e-480b-40e7-aa4d-21bd0659101d | memantine HCl 5 MG Oral Tablet [PSN] · memantine hydrochloride 5 MG Oral Tablet [SCD] | 2 | 3 | These Highlights do not include all the information needed to use memantine hydrochloride safely and effectively. See full prescribing information for Memantine Hydrochloride Tablets. Memantine hydrochloride tablets USP, for oral use Initial U.S. Approval: 2003 | 20230130 |
| dcbdb62a-a4e2-4058-b73c-46005f2a5d51 | memantine HCl 5 MG Oral Tablet [PSN] · memantine hydrochloride 5 MG Oral Tablet [SCD] | 2 | 3 | These highlights do not include all the information needed to use MEMANTINE HYDROCHLORIDE safely and effectively. See full prescribing information for MEMANTINE HYDROCHLORIDE. MEMANTINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 2003 | 20221008 |
| 802cbfd0-0dbe-638f-e053-2991aa0a6841 | memantine HCl 5 MG Oral Tablet [PSN] · memantine hydrochloride 5 MG Oral Tablet [SCD] | 2 | 3 | 20190507 | |
| 11d27c75-fdc0-f9da-e063-6394a90ac6b0 | memantine HCl 5 MG Oral Tablet [PSN] · memantine hydrochloride 5 MG Oral Tablet [SCD] | 2 | 2 | Memantine Hydrochloride Tablets, USP Rx only These highlights do not include all the information needed to use MEMANTINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for MEMANTINE HYDROCHLORIDE TABLETS. Initial U.S. Approval: 2003 | 20260108 |
| 30b4d5c4-0a31-c385-e063-6394a90adbce | memantine HCl 5 MG Oral Tablet [PSN] · memantine hydrochloride 5 MG Oral Tablet [SCD] | 2 | 2 | HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use MEMANTINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for MEMANTINE HYDROCHLORIDE TABLETS. MEMANTINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 2003 | 20250623 |
| 7a40ed9d-8853-b616-ff47-0c7b0fd28959 | memantine HCl 5 MG Oral Tablet [PSN] · memantine hydrochloride 5 MG Oral Tablet [SCD] | 2 | 2 | These highlights do not include all the information needed to use MEMANTINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for MEMANTINE HYDROCHLORIDE TABLETS. MEMANTINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 2003 | 20231226 |
| 47e4a696-fe2a-c905-e063-6294a90a7415 | memantine HCl 5 MG Oral Tablet [PSN] · memantine hydrochloride 5 MG Oral Tablet [SCD] | 2 | 1 | These highlights do not include all the information needed to use MEMANTINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for MEMANTINE HYDROCHLORIDE TABLETS. MEMANTINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 2003 | 20260108 |
| 3662b11a-354a-b683-e063-6394a90a0086 | memantine HCl 5 MG Oral Tablet [PSN] · memantine hydrochloride 5 MG Oral Tablet [SCD] | 2 | 1 | These highlights do not include all the information needed to use MEMANTINE HYDROCHLORIDE safely and effectively. See full prescribing information for MEMANTINE HYDROCHLORIDE. MEMANTINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 2003 | 20250530 |
| 2d54be77-75b2-76b3-e063-6294a90a0cc0 | memantine HCl 5 MG Oral Tablet [PSN] · memantine hydrochloride 5 MG Oral Tablet [SCD] | 2 | 1 | These highlights do not include all the information needed to use MEMANTINE HYDROCHLORIDE safely and effectively. See full prescribing information for MEMANTINE HYDROCHLORIDE. MEMANTINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 2003 | 20250204 |
| 4d48c958-b606-4427-8502-53450718eefb | memantine HCl 5 MG Oral Tablet [PSN] · memantine hydrochloride 5 MG Oral Tablet [SCD] | 2 | 1 | These highlights do not include all the information needed to use MEMANTINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for MEMANTINE HYDROCHLORIDE TABLETS. MEMANTINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 2003 | 20241021 |
| 4c5bef01-2e31-4181-a040-bb5a2fec949d | memantine HCl 5 MG Oral Tablet [PSN] · memantine hydrochloride 5 MG Oral Tablet [SCD] | 2 | 1 | These highlights do not include all the information needed to use memantine hydrochloride safely and effectively. See full prescribing information for memantine hydrochloride. MEMANTINE hydrochloride tablets, for oral use Initial U.S. Approval: 2003 | 20150527 |